Full Press Release Details
Therapeutics Announces First Quarter 2024 Financial Update and Pipeline Progress
Commercial manufacture of Kostaive on track
for delivery of initial 4 million doses in Q3
Kostaive European Marketing Authorization
Application approval decision expected Q3
Multiple Kostaive Phase 3 trials further
demonstrate breadth and durability of STARR vaccine platform
ARCT-2138 (LUNAR-FLU) Phase 1 topline immunogenicity
and safety data, anticipated in Q3
ARCT-810 (LUNAR-OTC) Phase 2 and ARCT-032 (LUNAR-CF)
Phase 1b interim data and update to be provided on July 1st
JP Morgan engaged to monetize investment in
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)--May. 8, 2024-- Arcturus
Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a global messenger RNA medicines company
focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced
its financial results for the first quarter ended March 31, 2024, and provided corporate updates.
"Arcturus continues to make encouraging
progress in both our vaccine and therapeutics pipeline," said Joseph Payne, President & CEO of Arcturus. "In collaboration
with our global vaccine partner CSL and their partner Meiji Seika Pharma, we are excited to begin the commercialization of Kostaive this
Mr. Payne continued, "We also look forward
to providing meaningful clinical study data updates July 1st, for each of our flagship mRNA therapeutic programs, ARCT-810
(OTC deficiency) and ARCT-032 (CF)."
"I am pleased to announce that we have engaged
JP Morgan to monetize our stake in ARCALIS, our JV manufacturing operation in Japan," stated Andrew Sassine, Chief Financial Officer
of Arcturus Therapeutics. "Additionally, I am pleased to announce we will begin to qualify for commercial milestones under our CSL
collaboration upon commencement of Kostaive revenues in Japan this year. Finally, our cash runway remains strong for at least three years
into the first quarter of fiscal year 2027."
Recent Corporate Highlights
Financial Results for the
three months ended March 31, 2024
Revenues in conjunction
with strategic alliances and collaborations:
Arcturus' primary sources
of revenues were from license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received
from research and development arrangements with pharmaceutical and biotechnology partners. For the three months ended March 31, 2024,
revenues were $38.0 million compared with $80.3 million for the three months ended March 31, 2023. The decrease
was primarily attributable to the CSL agreement as $78.2 million total revenue was recognized during the first quarter of 2023 upon the
achievement of a conditional payment and multiple milestones, compared to $32.4 million total revenue related to CSL during the first
quarter of 2024, resulting in a decrease of $45.8 million. The total decrease was primarily offset by an increase in revenue of $4.9 million
related to the agreement with BARDA.
operating expenses for the three months ended March 31, 2024, were $68.4 million compared with $65.5 million for
the three months ended March 31, 2023.
Research and development
and development expenses consist primarily of external manufacturing costs, in-vivo research studies and clinical trials performed by
contract research organizations, clinical and regulatory consultants, personnel-related expenses, facility-related expenses and laboratory
supplies related to conducting research and development activities. Research and development expenses were $53.6 million for
the three months ended March 31, 2024, compared with $51.8 million in the comparable period last year. The increase in
research and development expenses were primarily driven by the CSL and BARDA programs as well as Arcturus' internal OTC and Cystic
Fibrosis programs. Additionally, investments increased in early stage and discovery technologies, including the initiation of preclinical
research related to its Lyme Disease and Gonorrhea vaccine discovery programs.
General and Administrative
and administrative expenses primarily consist of salaries and related benefits for executive, administrative, legal and accounting functions
and professional service fees for legal and accounting services as well as other general and administrative expenses. General and administrative
expenses were $14.9 million for the three months ended March 31, 2024, compared with $13.8 million in the comparable period
last year. The increase in expenses resulted primarily from increased personnel expenses due to increased salaries, increased travel and
consulting expenses as well as escalated rent expense associated with facilities.
three months ended March 31, 2024, Arcturus reported a net loss of approximately $26.8 million, or ($1.00) per diluted share,
compared with a net income of $50.8 million, or $1.87 per diluted share in the three months ended March 31, 2023.
Cash Position and Balance
cash equivalents and restricted cash were $345.3 million as of March 31, 2024, and $348.9 million on December
31, 2023. Arcturus achieved a total of approximately $420.1 million in upfront payments and milestones from CSL as of March 31, 2024,
and expects to continue to receive future milestone payments from CSL supporting the ongoing development of the COVID and flu programs
and three additional vaccine programs by CSL. The expected cash runway extends at least three years based on the current pipeline and
programs through the first quarter of fiscal year 2027.
Earnings Call: Wednesday,
May 8, 2024 @ 4:30 pm ET
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California,
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA medicines and vaccines company with enabling technologies: (i) LUNAR
lipid-mediated delivery, (ii) STARR mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing
expertise. Arcturus developed the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine (Kostaive ) in the world to be approved.
Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused
on the manufacture of mRNA vaccines and therapeutics. Arcturus' pipeline includes RNA therapeutic candidates to potentially treat
ornithine transcarbamylase deficiency and cystic fibrosis, along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and
influenza. Arcturus' versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including
messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus'
technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe, Japan, China,
and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements
that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements,
including those regarding strategy, future operations, the likelihood of success and continued advancement of the Company's pipeline
(including ARCT-032 and ARCT-810) and partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus), the likelihood
of delivery of doses of Kostaive (including timing and volume thereof), the anticipated commercialization of Kostaive and the timing thereof,
the likelihood and timing of a European Marketing Authorization application approval decision for Kostaive, the monetization of Arcturus'
interests in ARCALIS JV in Japan, that preclinical or clinical data will be predictive of future clinical results, the likelihood and
timing of clinical study updates (including for ARCT-2138 (LUNAR-FLU), ARCT-032 (LUNAR-CF)), the qualification for commercial milestones
under the CSL collaboration, the continuation and expected recruitment in the Phase 3 pivotal study of ARCT-2303 candidate vaccine containing
the Omicron XBB.1.5 variant, the ongoing recruitment in the ARCT-2138 (LUNAR-FLU) Phase 1 study, the likelihood or timing of collection
of accounts receivables including expected future milestone and other payments from CSL, its current cash position and expected cash burn
and runway, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions
or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue
reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and
unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance
or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the
heading "Risk Factors" in Arcturus' most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions
to, the SEC, which are available on the SEC's website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any
intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as